Anavex Life Sciences Corp (AVXL)

[boi568]

I am not and never have been discussing a policy development guidance. Why would that be relevant?

I have been referencing the FDA's March 28 2013 policy that a drug applicant satisfy a functional primary co-endpoint in an early AD trial. The history is a bit of a mess: The FDA produced the 2013 policy, titled "Alzheimer's Disease: Developing Drugs for Treatment of Early Stage Disease; Draft Guidance for Industry." A Notice of Availability for the guidance (but not the guidance itself) was published in the Federal Register (78 FR 9396, February 16 2013). However, despite the title, the FDA had finished its work on the policy. It was, in government parlance, "Draft Final." It was not published in the Federal Register, since it was not a regulation, and I cannot find it on the FDA website.

The recent mab NDAs were compliant with the 2013 guidance regarding functional endpoints in early AD trials, probably because the later guidance revision attempts in 2018 and 2024 have never reached a conclusion and were still potentially evolving. Anavex has apparently gone the same route with its ADL endpoint in the 2b/3.